Abstract 2228

Introduction:

Novo Nordisk is developing turoctocog alfa, a human third generation recombinant FVIII for treatment of hemophilia A. During the pivotal trial in adult and adolescent previously treated patients with severe hemophilia A (guardian™1), subjects in need of surgery were able to participate in a subtrial to document efficacy and safety of turoctocog alfa in prevention of surgical bleeding. Pediatric (<12 years of age) previously treated patients in the guardian™3 trial were allowed to undergo minor surgery if needed during the trial. In addition, after completing these initial trials subjects were allowed to continue treatment with turoctocog alfa in the extension trial (guardian™2) which also includes a subtrial to document efficacy and safety of turoctocog alfa in prevention of surgical bleeding.

Methods:

We here describe surgeries performed within the guardian trials. For the ongoing guardian™2 extension trial, only cases included in the interim analysis (data cut-off 21NOV2011) are included.

Results:

In all, results from 10 major and 3 minor surgeries are included. Surgery indication was related to hemophilia joint disease in 8/13 cases. The hemostatic efficacy during and after surgery was rated on a 4-point scale (excellent, good, moderate and none) by the Investigator and/or Surgeon. Details and outcome of the individual surgeries performed are presented in Table 1. In addition, there were no safety concerns.

Table 1.

Details and outcome of surgical procedures in the guardian™ trials using turoctocog alfa for prevention of surgical bleeding.

Description of surgerySurgery indicationType of surgery (major/minor)Duration of surgery (hh:mm)Hemostatic response during surgeryHemostatic response after surgeryNo of blood transfusionsAgeExposure days since first exposure to turoctocog alfa at the time of surgery
1 Left knee replacement Arthropathy and chronic pain in left knee Major 1:30 Excellent Excellent 0 36 27 
2 Arthroscopy and synovectomy, partial meniscectomy Chronic synovitis Major 1:33 Good Excellent 0 30 154 
3 Right knee synoviectomia with extirpation of ostheosynthetic graft Arthropathy Major 1:00 Good Excellent 0 25 83 
4 Circumcision Religious Major 0:30 Excellent Excellent 0 14 106 
5 Left total hip arthroplasty Hemophilic arthropathy Major 1:40 Excellent Excellent 3 25 38 
6 Synovectomy, right ankle Recurrent hemarthrosis Major 1:21 Excellent Good 0 29 16 
7 Right ankle synovectomy Hemophilic arthropathy Major 1:05 Excellent Good 0 24 9 
8 Right ankle synovectomy Hemophilic arthropathy Major 1:19 Excellent Excellent 0 19 65 
9 Arthroscopy of left ankle Pain in left ankle Major 0:40 Excellent Excellent 0 24 421 
10 Left hip arthroprosthesis, reduction finger fracture Polytrauma Major 3:25 Good Excellent 1 55 437 
11 Removal of a central venous access port (guardian™ 3) SVC thrombosis Minor 0:27 Excellent NA 0 6 29 
12 Dental extraction (guardian™ 3) Tooth A caries Minor 0:10 Excellent NA 0 11 9 
13 Surgical extraction of tooth 48 and radix of tooth 12 Semi-impacted tooth 32 and rest radix of tooth 7 Minor 0:46 Excellent Excellent 0 23 141 
Description of surgerySurgery indicationType of surgery (major/minor)Duration of surgery (hh:mm)Hemostatic response during surgeryHemostatic response after surgeryNo of blood transfusionsAgeExposure days since first exposure to turoctocog alfa at the time of surgery
1 Left knee replacement Arthropathy and chronic pain in left knee Major 1:30 Excellent Excellent 0 36 27 
2 Arthroscopy and synovectomy, partial meniscectomy Chronic synovitis Major 1:33 Good Excellent 0 30 154 
3 Right knee synoviectomia with extirpation of ostheosynthetic graft Arthropathy Major 1:00 Good Excellent 0 25 83 
4 Circumcision Religious Major 0:30 Excellent Excellent 0 14 106 
5 Left total hip arthroplasty Hemophilic arthropathy Major 1:40 Excellent Excellent 3 25 38 
6 Synovectomy, right ankle Recurrent hemarthrosis Major 1:21 Excellent Good 0 29 16 
7 Right ankle synovectomy Hemophilic arthropathy Major 1:05 Excellent Good 0 24 9 
8 Right ankle synovectomy Hemophilic arthropathy Major 1:19 Excellent Excellent 0 19 65 
9 Arthroscopy of left ankle Pain in left ankle Major 0:40 Excellent Excellent 0 24 421 
10 Left hip arthroprosthesis, reduction finger fracture Polytrauma Major 3:25 Good Excellent 1 55 437 
11 Removal of a central venous access port (guardian™ 3) SVC thrombosis Minor 0:27 Excellent NA 0 6 29 
12 Dental extraction (guardian™ 3) Tooth A caries Minor 0:10 Excellent NA 0 11 9 
13 Surgical extraction of tooth 48 and radix of tooth 12 Semi-impacted tooth 32 and rest radix of tooth 7 Minor 0:46 Excellent Excellent 0 23 141 
View Large
Discussion:

Prevention of surgical bleeding is an important aspect of hemophilia treatment. In the present 13 surgeries, including all surgeries performed with turoctocog alfa in the phase 3 guardian™ trials, hemostatic efficacy during and after was rated as either excellent or good in each case. The results support that turoctocog alfa has an excellent safety and efficacy profile for use in hemophilia A.

Disclosures:

Santagostino:Novo Nordisk and Pfizer: Research Funding; Pfizer, Baxter, Bayer, CSL Behring, Kedrion, Grifols and Novo Nordisk: Consultancy; Bayer, Baxter, Pfizer, CSL Behring, Novo Nordisk, Biotest, Kedrion and Grifols: Speakers Bureau. Lentz:Novo Nordisk: Consultancy, Research Funding. Brand:Bayer: Travel support, Travel support Other; Novo Nordisk, Baxter, Pfizer: Advisory Boards, Advisory Boards Other; Novo Nordisk: Honoraria. Chowdary:Novo Nordisk: Consultancy. Savic:Novo Nordisk: Speakers Bureau. Lindblom:Novo Nordisk A/S: Employment.

Topics:
hemorrhage prophylaxis, surgical procedures, operative, hemophilia a, hemostatics, surgical blood loss, synovectomy, hemophilic arthropathy, joint disorders, arthroscopy, surgical procedures, minor

Author notes

*

Asterisk with author names denotes non-ASH members.

© 2012 by The American Society of Hematology
2012
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